Search Results

The StimQ Peripheral Nerve Stimulator (PNS) System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The StimQ PNS System is not intended to treat pain in the craniofacial region. The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator Receiver Kit. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The StimQ LLC (StimQ) StimQ Peripheral Nerve Stimulator System (System) is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. The System is comprised of an implantable stimulator (Freedom-8A, Freedom-4A or StimQ), receiver component (Receiver/RF Stylet), and an externally worn transmitter (StimQ Wearable Antenna Gear (SWAG)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for diagnostic or screening devices. Instead, it details a 510(k) premarket notification for a medical device (StimQ Peripheral Nerve Stimulator System) seeking substantial equivalence to legally marketed predicate devices.

The document primarily focuses on demonstrating that the StimQ PNS System is as safe and effective as its predicate devices, leveraging non-clinical performance data and showing identical or similar technological characteristics and materials.

Here's a breakdown based on the information available and what is not present:

1. Table of acceptance criteria and the reported device performance:

   • The document does not provide a table of acceptance criteria with corresponding reported device performance metrics in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).
   • Instead, it lists various non-clinical tests conducted (e.g., thermal shock, leakage current, mechanical testing, MRI compatibility, ingress of water, electromagnetic compatibility) against recognized standards (e.g., AAMI ANSI ISO 14708-3, ASTM F2182-11a, IEC 60601-1, IEC 60529, IEC 60601-1-2). The "reported device performance" for these tests is generally stated as "passed all criteria," "complies with design requirements," "no irreversible damage," or "fully functional."
     • Example (from text, not a structured table):
       • Acceptance Criteria (implicit from standard): Protection from temperature change ("functional" / "safe rating" / "no physical damage" / "fully operational").
       • Reported Device Performance: "The Stimulators were functional, receiving a safe rating following post visual inspection and passed the change of temperature testing." and "The SWAG met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational."

2. Sample sized used for the test set and the data provenance:

   • The document does not specify sample sizes for the non-clinical tests in terms of number of devices tested. It refers generally to "all tested paths for all tested samples" or "any stimulator samples" or "all tested stylets in all tested stimulator samples."
   • The data provenance is non-clinical testing, performed by the manufacturer, leveraging data from previously cleared devices (K170141, K152178, K150517, K160600, K162161, K141399). This appears to be retrospective in terms of referencing prior submissions, and laboratory/bench testing rather than patient clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not applicable as there is no diagnostic test or image interpretation involved requiring expert ground truth for a test set. The tests are engineering and biological safety assessments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not applicable as there is no diagnostic test or image interpretation involved.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This information is not applicable. The device is an implanted peripheral nerve stimulator for pain management, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This information is not applicable. The device is a physical medical device, not an algorithm. Performance testing was done on the device's physical and electrical characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the non-clinical tests, the "ground truth" or reference is adherence to established industry standards and regulatory requirements (e.g., ISO, ASTM, IEC standards) and the product's own design specifications. For biocompatibility, it's ISO 10993-1.

8. The sample size for the training set:

   • This is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

   • This is not applicable as the device is not an AI/ML algorithm that requires a training set.

In summary: The provided document is a 510(k) submission focused on demonstrating substantial equivalence for a medical device by referencing extensive non-clinical testing performed against established standards and leveraging data from previously cleared predicate devices. It does not involve diagnostic performance metrics, clinical studies, or AI/ML components requiring the type of acceptance criteria and study details requested in the prompt.

Ask a specific question about this device

The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either Kit Freedom-4A Stimulator or the Receiver Kit Freedom-8A Stimulator. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for spinal column stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or lower limbs including unilateral or bilateral pain. The therapy utilizes pulsed electrical current to create an energy field that acts on nerves near the spinal column. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator), receiver component (Receiver), and an externally worn transmitter (Wearable Antenna Assembly (WAA)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.

The provided text concerns a 510(k) premarket notification for the Freedom Spinal Cord Stimulator (SCS) System (K170141). This document primarily focuses on demonstrating substantial equivalence to a predicate device (K162161) rather than detailing a study that establishes acceptance criteria and proves the device meets those criteria from scratch.

The submission states: "This submission is identical to K162161, but includes summaries of performance testing to support MR Conditional labeling of the Freedom-8A SCS System. No modifications to the Freedom SCS System of K162161 were made in support of this submission." This indicates that the device's fundamental performance was established in the prior K162161 submission, and K170141 specifically addresses MR Conditional labeling.

Therefore, many of the requested details regarding acceptance criteria for a new study, sample sizes for test sets, expert involvement for ground truth, and adjudication methods are not present in this document as it relies on pre-existing data and a demonstration of substantial equivalence rather than a de novo clinical trial or performance study proving new criteria.

However, based on the information provided, we can extract the types of performance tests conducted and the standards against which the device was evaluated, which serve implicitly as acceptance criteria for demonstrating equivalent performance to the predicate device and for MR Conditional labeling.

Here's an attempt to answer the questions based on the provided text, highlighting where information is absent due to the nature of this 510(k) submission:

Acceptance Criteria and Device Performance (Implicit from Compliance Statements)

The document doesn't explicitly list "acceptance criteria" in a table form with numerical targets and then report performance against them for all aspects. Instead, it states compliance with various standards and successful completion of tests. The "acceptance criteria" are implied by the standards cited and the statement that the device "complies" or "passed" these tests.

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated for each test. The document mentions "all tested samples," "all tested stylets," etc., implying a sample was used, but the exact number is not provided.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests described are primarily bench testing and engineering evaluations, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. The document describes non-clinical performance testing (bench testing, engineering evaluations). There is no mention of human experts establishing "ground truth" for these technical performance tests in the way one would for diagnostic AI. The "ground truth" for these tests comes from adherence to specific engineering and material standards (e.g., ASTM, ISO, IEC).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. Adjudication methods are typically relevant for human reader studies or where expert consensus is needed to establish ground truth in complex or ambiguous cases. This document details engineering and compliance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was done. This is a medical device (spinal cord stimulator), not an AI diagnostic tool that assists human readers. The submission explicitly states: "There was no clinical testing required to support the medical device, as the indications for use are equivalent to the legally marketed predicate devices."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This isn't an algorithm that performs a standalone diagnostic function. It's a medical device. The "performance" described is the device's physical and electrical characteristics and its ability to function within specified parameters, especially regarding MR compatibility.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable in the conventional sense of ground truth for diagnostic AI. The ground truth for these tests is defined by established engineering standards, material properties, and functional specifications of the device components (e.g., force measurements, electrical outputs, temperature limits, artifact presence).

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

Ask a specific question about this device